Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2025-09-03
2027-03-28
Brief Summary
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* Establish optimal cutoffs for EUS-SWE in reference to liver biopsies staging system for liver fibrosis
* Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (screening scores).
Participants will undergo:
* Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI)
* Liver biopsy
* FibroScan
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Detailed Description
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This study has been designed as a post-market clinical registry to evaluate the effectiveness of Endoscopic Ultrasound with Shear Wave Elastography to estimate hepatic fibrosis in patients with chronic liver disease. All consenting, eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis meeting the inclusion criteria will be consecutively enrolled into the study and assigned a unique study identification number.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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All subjects enrolled
Consecutive, eligible patients reporting for an endoscopic ultrasound liver biopsy and FibroScan for evaluation of liver fibrosis will be enrolled. EUS-SWE/ATI will be compared to liver biopsy pathology results, FibroScan (VCTE and CAP) results, and screening scores).
Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging
EUS combines ultrasound technology with endoscopy to gain an internal vantage point to obtain higher resolution ultrasound images. Shear Wave is a software option on the ultrasound system EUS that provides an advanced measure and dynamic display of tissue stiffness which is being evaluated for use in assessing liver fibrosis. Attenuation Imaging (ATI) is a novel application that provides the capability to quantify and color-code the changes in attenuation coefficient of the liver that may arise with changes in liver composition (e.g., increased fat levels).
FibroScan
A small ultrasound probe to measure the velocity of a sound wave passing through the liver. This is converted into kilopascals (kPa), which is used to assess liver fibrosis.
Liver biopsy
A biopsy of liver tissue could be obtained under endoscopic ultrasound guidance, interventional radiology (percutaneously), or surgically.
Endoscopic Ultrasound-guided liver biopsy provides high resolution images of left lobe of the liver and a good portion of the right lobe of the liver. This, coupled with Doppler capability, allows the physician to direct the biopsy needle safely into the liver for sampling under real time image guidance.
Interventions
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Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging
EUS combines ultrasound technology with endoscopy to gain an internal vantage point to obtain higher resolution ultrasound images. Shear Wave is a software option on the ultrasound system EUS that provides an advanced measure and dynamic display of tissue stiffness which is being evaluated for use in assessing liver fibrosis. Attenuation Imaging (ATI) is a novel application that provides the capability to quantify and color-code the changes in attenuation coefficient of the liver that may arise with changes in liver composition (e.g., increased fat levels).
FibroScan
A small ultrasound probe to measure the velocity of a sound wave passing through the liver. This is converted into kilopascals (kPa), which is used to assess liver fibrosis.
Liver biopsy
A biopsy of liver tissue could be obtained under endoscopic ultrasound guidance, interventional radiology (percutaneously), or surgically.
Endoscopic Ultrasound-guided liver biopsy provides high resolution images of left lobe of the liver and a good portion of the right lobe of the liver. This, coupled with Doppler capability, allows the physician to direct the biopsy needle safely into the liver for sampling under real time image guidance.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Willing and able to provide informed consent
3. Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \>10% total body weight
4. Patient scheduled to undergo or have undergone FibroScan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \>10% total body weight
5. BMI \>/=28
6. Clinical suspicion of MASLD (hepatic steatosis with at least one of five cardiometabolic risk factors: 1) overweight or obesity, 2) elevated glucose, 3) low HDL-C, 4) hypertension, and/or 5) hypertriglyceridemia) or MASH (additionally characterized by the presence of inflammation and hepatocellular ballooning) with or without fibrosis, as determined by non-invasive or minimally invasive techniques (e.g. abdominal ultrasound, FibroScan)
Exclusion Criteria
2. Prior history of Hepatitis B or C infection
3. Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)
4. Histological evidence of other concomitant chronic liver disease on biopsy
5. Inadequate liver biopsy
6. Prior history of or current excess alcohol consumption (\>140 g/week and \>210 g/week for females and males, respectively) documented in EMR
18 Years
ALL
No
Sponsors
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Olympus Corporation of the Americas
INDUSTRY
Responsible Party
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Principal Investigators
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Marvin Ryou, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital, Boston, MA
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-GI-02
Identifier Type: -
Identifier Source: org_study_id
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